Generally, this invention relates to a device useful for a patient to collect a sample of oral fluid for purposes of mailing the sample to a testing laboratory for various diagnostic measurement and testing of the patient""s oral fluid, thereby indicating the presence of conditions such as infectious diseases in the individual. More specifically, the present invention relates to a sample collection device which a person can place in their mouth to collect an oral fluid sample. This oral collection device is then placed within a sealing pouch and then in a mailer and sent to a testing laboratory.
It has been well-known that oral fluid samples may contain antibodies or antigens to various diseases, such as sexually transmitted diseases, for example human immuno deficiency virus (HIV). Further, other diseases and other states may also be tested in a patients oral fluid: Hepatitis B; Rubella; cytomegalovirus (CMV); hepatitis C virus (HCV); Toxoplasmosis; hepatitis A virus (HAV); Lyme Disease; testing for drug abuse; therapeutic drug monitoring; or DNA diagnostics.
Heretofore, it has been a known practice to take oral samples from a patient at a laboratory in order to determine the presence of such analytes. However, it has become desirable to be able to have the patient take a sample at home, and then send it in the mail to a testing service. The service then analyzes the sample in the laboratory and reports the result in confidence to the patient.
The collection of oral fluid samples from outside of a laboratory and then mailing them to a testing service presents its own difficulties. For instance, the sampling device must be reliable. It must be able to be preserved. It must be sealable within a device so that the sample does not leak or get contaminated during mailing. The sealing mechanism must be impermeable so that the sealing mechanism itself cannot be punctured during mailing. And, as an overriding concern, all of these functions must take place in a device which is small enough to incur low mailing costs while meeting postal regulations. Thus far, it has been unknown in the industry to provide for such a device.
Furthermore, once the device arrives at the testing laboratory, it is then desirable to recover the sample from the strip (e.g., by centrifugation). It may be desirable to keep the sample within the original pouch in which the sample has been mailed (to maintain sample identification and also to allows taking multiple testing in various analytical procedures), so that once again the sample is not in any way compromised. Therefore, it is desirable to have a mechanism which is capable of centrifugation within its own mailer.
The invention described herein provides for such concerns. There is disclosed a sample collection device which is comprised of a collection portion in the form of an absorbent cotton pad. This absorbent cotton pad may be placed in the mouth (generally on the tongue, although other locations may be acceptable) to collect an oral fluid sample. A plastic frame surrounds the pad to help hold the fluid collected thereon and maintain pad integrity. The handle of the device incorporates a sealing mechanism for sealing engagement with the collar of the preservative pouch. A barcode label is placed on the oversized handle as a patient identifying mechanism.
A narrow extension of the pad will continue up the central, hollow stem of the handle. A window is placed in the neck of the stick and a chemical is coated on the pad underneath the window, the chemical being chosen so that it will change color when sufficient oral fluid has been taken up by the pad. Various schemes have been devised for effecting the color change. The product is designed so that a consumer with no medical training will be able to easily and safely collect an oral fluid sample, know when there is a sufficiently collected sample, preserve the sample so that it survive shipment to the laboratory and receive information about HIV serotatus or other disease or drug in a completely confidential manner.
The preservative pouch of the present invention contains a pair of seals. The first seal, located proximally to the user, enables a preservative which is maintained within the pouch to be sealed during shipment of the pouch to the user. Thereafter, the user punctures the first seal upon placement of the reagent pad into the pouch. The sealing mechanism contained on the reagent pad then seals at the opening in the pouch to maintain the reagent pad in sealing arrangement within the pouch.
At its distal end, the pouch contains a second sealing mechanism, whose use will be further explained below. However, it is to be understood that this sealing mechanism helps protect the preservative as well as the oral sample, within the pouch during shipment from the user back to the testing laboratory.
Both the flexible pouch and the pad contained in sealing arrangement are inserted together into a mailing pouch. The mailing pouch is arranged so that the preservative pouch is not able to be punctured during mailing. This preservative pouch furthermore contains a latching mechanism so that the reagent strip and preservative pouch can be latched within the mailing pouch to be placed within a mailer and returned to the testing laboratory. This mailing pouch further contains a cuvette which is able to be punctured in the laboratory to obtain a portion of the sample of oral fluid collected after such original sample is centrifuged in its original pouch.
In use, the mechanism of the present invention is placed in the mail with the reagent pad holding collected oral sample within the pouch. This combination is placed into the mailing pouch and sent to the laboratory in a first class postage mailer. When at the laboratory, the technician can puncture the cuvette so that the user can take a separate sample of the sample already collected. To do so, the laboratory technician cuts away a portion of the mailing pouch, and places the remaining mailing pouch with the preservative pouch intact within a centrifuge. Or, the technician can remove the preservative pouch and reagent pad and thereafter place it within a centrifuge.
The preservative pouch contains the heretofore mentioned second distal seal. This seal is now broken during centrifugation. At this point, the oral sample which has been preserved through mailing is collected by within the mailing pouch and can be used to determine presence of various antibodies in any of a series well-known tests for the existence of such antibodies or other analytes.